EP3357503A1 - Composition pharmaceutique de traitement d'un syndrome métabolique - Google Patents

Composition pharmaceutique de traitement d'un syndrome métabolique Download PDF

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Publication number
EP3357503A1
EP3357503A1 EP18162214.3A EP18162214A EP3357503A1 EP 3357503 A1 EP3357503 A1 EP 3357503A1 EP 18162214 A EP18162214 A EP 18162214A EP 3357503 A1 EP3357503 A1 EP 3357503A1
Authority
EP
European Patent Office
Prior art keywords
fgf
glp
pharmaceutical composition
insulin
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP18162214.3A
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German (de)
English (en)
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EP3357503B1 (fr
Inventor
Mark Sommerfeld
Hans-Ludwig Schaefer
Oliver Boscheinen
Paul Habermann
Ercole Rao
Matthias Dreyer
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Sanofi SA
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Sanofi SA
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41718306&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP3357503(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi SA filed Critical Sanofi SA
Priority to EP19195239.9A priority Critical patent/EP3607964B1/fr
Publication of EP3357503A1 publication Critical patent/EP3357503A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/50—Fibroblast growth factor [FGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Definitions

  • FGF-21 compound is defined as a compound showing FGF-21 activity, in particular comprising (i) native FGF-21, especially human FGF-21, in particular human FGF-21 as shown in SEQ ID NO: 1, or (ii) a FGF-21 mimetic with FGF-21 activity.
  • adipocytes are starved for 3 hours in DMEM/0.1% BSA, stimulated with FGF-21 for 24 hours, and washed twice with KRP buffer (15 mM HEPES, pH 7.4, 118 mM NaCl, 4.8 mM KCl, 1.2 mM MgSO 4 , 1.3 mM CaCl 2 , 1.2 mM KH 2 PO 4 , 0.1% BSA), and 100 ⁇ l of KRP buffer containing 2-deoxy-D-[ 14 C]glucose (2-DOG) (0.1 ⁇ Ci, 100 ⁇ M) is added to each well.
  • KRP buffer 15 mM HEPES, pH 7.4, 118 mM NaCl, 4.8 mM KCl, 1.2 mM MgSO 4 , 1.3 mM CaCl 2 , 1.2 mM KH 2 PO 4 , 0.1% BSA
  • FGF-21 muteins are described in e.g. WO2005/061712 , WO2006/028595 , WO2006/028714 , WO2006/065582 or WO2008/121563 .
  • Exemplary muteins are muteins which have a reduced capacity for O-glycosylation when e.g. expressed in yeast compared to wild-type human FGF-21, e.g. human FGF-21 with a substitution at position 167 (serine), e.g.
  • FGF-21 fusion proteins are described in e.g. WO2004/110472 or WO2005/113606 , for example a FGF-21-Fc fusion protein or a FGF-21-HAS fusion protein.
  • Fc means the Fc portion of an immunoglobulin, e.g. the Fc portion of IgG4.
  • HSA human serum albumin.
  • Human GLP-1(7-37) possesses the amino acid sequence of SEQ ID NO: 3.
  • Human GLP-1(7-36)amide possesses the amino acid sequence of SEQ ID NO: 4.
  • Extendin-4 possesses the amino acid sequence of SEQ ID NO: 5.
  • Exenatide possesses the amino acid sequence of SEQ ID NO: 6 and oxyntomodulin the amino acid sequence of SEQ ID NO: 7.
  • the amino acid sequence of lixisenatide is shown in SEQ ID NO: 8.
  • the structure of lixisenatide is based on exendin-4(1-39) modified C-terminally with six additional lysine residues in order to resist immediate physiological degradation by DPP-4 (dipeptidyl peptidase-4).
  • the amino acid sequence of AVE0010 is shown in SEQ ID NO: 9
  • the pharmaceutical composition additionally contains at least one anti-diabetic drug and/or at least one DPP-4 inhibitor.
  • insulin analogues in which the C-terminal carboxylic acid of either the A-chain or the B-chain, or both, are replaced by an amide.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP18162214.3A 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique Active EP3357503B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19195239.9A EP3607964B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP10305070A EP2359843A1 (fr) 2010-01-21 2010-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP20140163127 EP2754449A1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
PCT/EP2011/050793 WO2011089203A1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP11700669.2A EP2525807B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP16205881.2A EP3216459B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique

Related Parent Applications (4)

Application Number Title Priority Date Filing Date
EP11700669.2A Division EP2525807B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP20140163127 Division EP2754449A1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP16205881.2A Division-Into EP3216459B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP16205881.2A Division EP3216459B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP19195239.9A Division EP3607964B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP19195239.9A Division-Into EP3607964B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique

Publications (2)

Publication Number Publication Date
EP3357503A1 true EP3357503A1 (fr) 2018-08-08
EP3357503B1 EP3357503B1 (fr) 2019-10-30

Family

ID=41718306

Family Applications (7)

Application Number Title Priority Date Filing Date
EP11174543A Withdrawn EP2460527A1 (fr) 2010-01-21 2010-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP10305070A Withdrawn EP2359843A1 (fr) 2010-01-21 2010-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP16205881.2A Active EP3216459B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP19195239.9A Active EP3607964B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP18162214.3A Active EP3357503B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP20140163127 Withdrawn EP2754449A1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP11700669.2A Active EP2525807B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique

Family Applications Before (4)

Application Number Title Priority Date Filing Date
EP11174543A Withdrawn EP2460527A1 (fr) 2010-01-21 2010-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP10305070A Withdrawn EP2359843A1 (fr) 2010-01-21 2010-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP16205881.2A Active EP3216459B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique
EP19195239.9A Active EP3607964B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique de traitement d'un syndrome métabolique

Family Applications After (2)

Application Number Title Priority Date Filing Date
EP20140163127 Withdrawn EP2754449A1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique
EP11700669.2A Active EP2525807B1 (fr) 2010-01-21 2011-01-21 Composition pharmaceutique pour le traitement d'un syndrome métabolique

Country Status (34)

Country Link
US (4) US20130203651A1 (fr)
EP (7) EP2460527A1 (fr)
JP (3) JP5925130B2 (fr)
KR (2) KR20180049194A (fr)
CN (1) CN102753192B (fr)
AR (1) AR079939A1 (fr)
AU (2) AU2011208650B2 (fr)
BR (1) BR112012017949A2 (fr)
CA (1) CA2787131A1 (fr)
CL (1) CL2012002031A1 (fr)
CO (1) CO6592082A2 (fr)
CY (2) CY1116026T1 (fr)
DK (2) DK3216459T3 (fr)
ES (3) ES2930750T3 (fr)
HK (1) HK1259492A1 (fr)
HR (2) HRP20150029T1 (fr)
HU (1) HUE041442T2 (fr)
IL (2) IL220862A0 (fr)
LT (1) LT3216459T (fr)
MA (1) MA33931B1 (fr)
MX (2) MX336751B (fr)
NZ (1) NZ601306A (fr)
PH (1) PH12012501403B1 (fr)
PL (2) PL3216459T3 (fr)
PT (2) PT2525807E (fr)
RS (1) RS53742B1 (fr)
RU (2) RU2593960C2 (fr)
SG (2) SG10201500465XA (fr)
SI (2) SI3216459T1 (fr)
TR (1) TR201820147T4 (fr)
TW (2) TWI561241B (fr)
UY (1) UY33194A (fr)
WO (1) WO2011089203A1 (fr)
ZA (1) ZA201204996B (fr)

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WO2012028172A1 (fr) 2010-08-30 2012-03-08 Sanofi-Aventis Deutschland Gmbh Utilisation de lixisenatide pour fabrication de médicament pour traitement du diabète sucré de type 2
US9821032B2 (en) 2011-05-13 2017-11-21 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
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EP3104873B1 (fr) 2014-02-13 2019-09-04 Technische Universität München Fgf-8 pour son utilisation dans le traitement des maladies ou des troubles de l'homéostasie énergétique
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CN104383523A (zh) * 2014-10-22 2015-03-04 山西医科大学 Cjc-1131降糖药物在治疗阿尔茨海默病的用途
CN114129709A (zh) 2014-10-23 2022-03-04 恩格姆生物制药公司 包含肽变异体的药物组合物及其使用方法
US10434144B2 (en) 2014-11-07 2019-10-08 Ngm Biopharmaceuticals, Inc. Methods for treatment of bile acid-related disorders and prediction of clinical sensitivity to treatment of bile acid-related disorders
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TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患之治療
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JP6728352B2 (ja) 2015-11-09 2020-07-22 エヌジーエム バイオファーマシューティカルス，インコーポレーテッド 胆汁酸に関係した障害の治療方法
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EP4470551A3 (fr) * 2017-03-14 2025-02-26 Sunshine Lake Pharma Co., Ltd. Protéines de fusion à double cible comprenant la partie fc d'une immunoglobuline
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CN112566655B (zh) * 2018-06-21 2025-11-07 赛诺菲 具有优化的活性比率的fgf21化合物/glp-1r激动剂组合
CN115322794B (zh) 2020-01-11 2025-09-19 北京质肽生物医药科技有限公司 Glp-1和fgf21的融合蛋白的缀合物
KR20210149366A (ko) * 2020-06-02 2021-12-09 주식회사 고바이오랩 Icam-2에 결합하는 물질을 유효성분으로 포함하는 대사질환 예방 또는 치료용 약학 조성물
WO2022002408A1 (fr) * 2020-07-02 2022-01-06 Sanofi Protéines hybrides fgf21/agoniste de glp-1r
US12054551B2 (en) 2020-07-02 2024-08-06 Sanofi FGFR1/KLB targeting agonistic antigen-binding proteins and conjugates thereof with GLP-1R agonistic peptides
WO2022144021A1 (fr) * 2021-01-04 2022-07-07 华领医药技术（上海）有限公司 Composition pharmaceutique contenant de la dorzagliatine et un analogue de peptide-1 de type glucagon

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